Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A two year open label single arm study of teriparatide in secondary care. - Teriparatide Treatment in Postmenopausal Women: Mechanism of Actio
- Conditions
- OsteoporosisMedDRA version: 12.1 Level: LLT Classification code 10031282 Term: Osteoporosis
- Registration Number
- EUCTR2010-021009-19-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Subjects must:
- Have a BMD T-score (at the lumbar spine or total hip) of less than or equal to -2.5
- Be female
- Be at least 5 years post menopausal (more than 5 years since their last menstrual period) but <85 years old.
- Be ambulatory
- Be able and willing to participate in the study and provide written informed consent
- Have a serum 25 (OH)2 vitamin D3 >50 nmol/L (after vitamin D3 loading)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients will not be admitted to the study if they exhibit any of the following:
- Evidence of a clinically significant organic disease which could prevent the patient from completing the study
- A BMI less than 18 or greater than 35
- Abuse of alcohol or use illicit drugs (information obtained from medical history) or who consumed more than 4 servings of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers)
- Any history of cancer within the past 5 years excluding skin cancer non melanomas
- Any history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health including Paget’s disease of bone
- Chronic renal disease (as defined by an estimated glomerular filtration rate of = 30mL/min)
- Acute or chronic hepatic disease
- Malabsorption syndromes
- Hyperthyroidism as manifested by TSH outside the lower limit of the normal range
- Hyperparathyroidism
- Hypocalcemia or hypercalcemia
- Osteomalacia
- Cushing’s syndrome
- Current use of glucocorticoid therapy
- A corrected serum calcium less than 2.2 mmol/L and a PTH above 100ng/L (that persists after testing and treatment for vitamin D deficiency)
- A history of any known condition that would interfere with the assessment of DXA at either lumbar spine or femoral neck
- Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator
- Any previous use of bisphosphonate
- Use any of the following medications within 12 months of starting study drug
- Any fluoride with the exception of use for oral hygiene
- Strontium Ranelate
- Other bone agents (e.g. SERM, isoflavones, HRT)
- Participation in another clinical trial involving active therapy 3 months prior to enrolment
- Less than 5 years since menopause
- Bilateral fractures in the measurement regions (hip, tibia and forearm).
- Recent fracture within the last 12 months
- Prior radiation therapy which may involve the skeleton
- Hypersensitivity to teriparatide or any of its exipients
- Unexplained elevations of alkaline phosphatase
- Any known contraindication to the use of teriparatide.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: 1. What is the effect of teriparatide on the axial and appendicular skeleton and on cortical and trabecular bone as assessed by QCT?<br> 2. What are the time course and the magnitude of effect of teriparatide on biochemical markers of bone turnover?<br> ;<br> Secondary Objective: 1. Does the 12 week HR-pQCT response to teriparatide predict the BMD response at 104 weeks?<br> 2. Do the early changes in biochemical markers of bone turnover predict the BMD response to teriparatide at 52 and 104 weeks?<br> ;Primary end point(s): Change in volumetric BMD of the spine by QCT (vertebrae L1-3) at 104 weeks.
- Secondary Outcome Measures
Name Time Method